MAUDE Adverse Event Report: PHILIPS ULTRASOUND INC. IE33; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number IE33

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 03/03/2015

Event Type  malfunction  

Event Description

Ie-33 probe #boh1lh lost part of orange mechanical lens on the transducer face.Called philips, took machine out of useage,tagged, and waiting for philips to service the device.
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manufacturer response for ultrasound probe, phillips (per site reporter).
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unknown.

• Brand Name: IE33
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND INC.; 1 echo dr; reedsville PA 17084
• MDR Report Key: 4608398
• MDR Text Key: 20066292
• Report Number: 4608398
• Device Sequence Number: 1
• Product Code: IYO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: IE33
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2015
• Patient Sequence Number: 1
• Patient Age: 73 YR